POS0806 OPTIMIZATION OF TOCILIZUMAB THERAPY IN GIANT CELL ARTERITIS. A MULTICENTER REAL-LIFE STUDY OF 471 PATIENTS.
Authors: C. Álvarez-Reguera, M. Calderón-Goercke, J. Loricera, C. Moriano, S. Castañeda, J. Narváez, V. Aldasoro, O. Maiz, R. Melero, I. Villa-Blanco, P. Vela-Casasempere, S. Romero-Yuste, J. L. Callejas-Rubio, E. De Miguel, E. Galíndez-Agirregoikoa, F. Sivera, C. Fernández-López, C. Galisteo, I. Ferraz-Amaro, J. Sanchez-Martin, L. Sanchez-Bilbao, J. L. Hernández Hernández, M. Á. González-Gay, R. Blanco
Journal: Annals of the Rheumatic Diseases (2022)

Background Tocilizumab (TCZ) has shown to be useful in the treatment of large-vessel vasculitis, including giant cell arteritis (GCA) (1-4 ). There is general agreement on the initial and the standard maintenance dose of TCZ. However, information on duration and optimization of TCZ in GCA is really scarce. Objectives Our aim was to assess the effectiveness and safety of TCZ therapy optimization in an unselected wide series of GCA in real-world clinical practice. Methods Multicenter study on 471 patients with GCA who received TCZ therapy. Once complete remission was reached (n=231) TCZ was optimized in 125 patients. We compared patients in whom TCZ was optimized (TCZ OPT group) or not (TCZ NON-OPT group). Complete remission was defined as normalization of clinical and analytical (CRP and ESR) data. Optimization was done by decreasing the dose and/or prolonging the TCZ dosing interval progressively. We performed a comparison in effectiveness and safety parameters between optimized and non-optimized patients. Results We evaluated 231 GCA patients treated with TCZ with complete remission. No demographic or laboratory data differences was observed at TCZ onset between both groups (Table 1). The mean prednisone dose was higher in the TCZ NON-OPT group at TCZ onset. The first TCZ optimization was performed after a median [25-75th] follow-up of 12 [6-17] months. Table 1. Main general features at TCZ onset of 231 GCA patients with prolonged remission. OPTIMIZED-TCZ GROUP (n=125 ) NON-OPTIMIZED TCZ GROUP (n=106 ) p GENERAL FEATURES Age, years, mean± SD 72.7±8.6 74±8.7 0.197 Sex, female/male n (% female) 91/34 (72.8) 74/32 (69.8) 0.616 Time from GCA diagnosis to TCZ onset (months), median [IQR] 8 [2-21.5] 5 [2-21] 0.384 SYSTEMIC MANIFESTATIONS Fever, n (%) 14 (11.2) 15 (14.2) 0.500 Constitutional syndrome, n (%) 54 (43.2) 39 (36.8) 0.322 PMR, n (%) 75 (60) 69 (65.1) 0.426 ISCHEMIC MANIFESTATIONS Visual involvement, n (%) 14 (11.2) 16 (15.1) 0.380 Headache, n (%) 66 (52.8) 62 (58.5) 0.386 Jaw claudication, n (%) 24 (19.2) 25 (23.6) 0.417 AORTITIS (large-vessel involvement), n (% ) 65 (52) 42 (39.6) 0.060 ANALYTICAL FINDINGS ESR, mm/1st hour, mean (SD) 39.1±29.3 37.5±33.5 0.334 CRP, mg/dL mean (SD) 2.6± 3.4 2.7± 4 0.305 Hemoglobin, g/dL, mean (SD) 13.5±9.6 12.9±1.5 0.153 GLUCOCORTICOIDS Prednisone dose, mg/d mean (SD) 20.3±16.4 27±17.8 0.001 Abbreviations: CRP: C-reactive protein; ESR: erythrocyte sedimentation rate; GCA: giant cell arteritis; IQR: interquartile range; IV: intravenous; PMR: polymyalgia rheumatica; SC: subcutaneous; SD: standard deviation; TCZ: tocilizumab. The median prednisone dose at first TCZ optimization was 2.5 [0-5] mg/day. At the end of follow-up prolonged remission was observed in 78.2% of TCZ OPT group compared with 66.7% in the TCZ NON-OPT group (p= 0.001) (Figure 1). Seven (5.6%) of the 125 optimized cases relapsed. Serious adverse events were similar in both groups, while serious infections were more frequent in the TCZ NON-OPT group (p=0.009). Conclusion Once complete remission is reached in GCA patients under TCZ treatment, optimization of biologic may be performed. Based on our experience it could be performed by reducing the dose or by prolonging dosing interval of TCZ. It seems to be an effective and safe practice. References [1]Calderón-Goercke M, et al. Semin Arthritis Rheum. 2019; 49: 126-135. PMID: 30655091 [2]Loricera J, et al. Clin Exp Rheumatol. 2016; 34: S44-53. PMID: 27050507 [3]Prieto-Peña D, et al. Ther Adv Musculoskelet Dis. 2021; 13: 1759720X211020917. PMID: 34211589 [4]Loricera J, et al. Int Immunopharmacol. 2015; 27: 213-9. PMID: 25828585 Disclosure of Interests Carmen Álvarez-Reguera: None declared, Monica Calderón-Goercke: None declared, J. Loricera: None declared, Clara Moriano: None declared, Santos Castañeda: None declared, J. Narváez: None declared, Vicente Aldasoro: None declared, Olga Maiz: None declared, Rafael Melero: None declared, Ignacio Villa-Blanco: None declared, Paloma Vela-Casasempere: None declared, Susana Romero-Yuste: None declared, Jose Luis Callejas-Rubio: None declared, Eugenio de Miguel: None declared, E. Galíndez-Agirregoikoa: None declared, Francisca Sivera: None declared, Carlos Fernández-López: None declared, Carles Galisteo: None declared, Iván Ferraz-Amaro: None declared, Julio Sanchez-Martin: None declared, Lara Sanchez-Bilbao: None declared, Jose Luis Hernández Hernández: None declared, Miguel Á. González-Gay Consultant of: Abbvie, Pfizer, Roche, Sanofi and MSD., Grant/research support from: Abbvie, MSD, Jansen and Roche., Ricardo Blanco Consultant of: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD, Grant/research support from: Abbvie, MSD and Roche.